BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD CONVENTIONAL NEEDLES

    MDR report key: 20447255 · Received October 14, 2024

    Report

    Report Number
    3002682307-2024-00209
    Event Type
    Malfunction
    Date Received
    October 14, 2024
    Date of Event
    October 12, 2024
    Report Date
    November 20, 2024
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMI
    UDI-DI
    00382903031290
    PMA / PMN Number
    UNK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    H.3. A FOLLOW UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION, A DEVICE EVALUATION, OR A DEVICE HISTORY REVIEW IS COMPLETED.

    Additional Manufacturer Narrative · 0

    A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 303129 AND LOT NUMBER 240504. THE REVIEW DID NOT REVEAL ANY DETECTED ABNORMALITIES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT AND ALL QUALITY TESTS WERE FOUND TO BE WITHIN SPECIFICATION. AS SAMPLES WERE UNAVAILABLE FOR RETURN, TWENTY RETAINED SAMPLES OF THE SAME LOT NUMBER WERE OBTAINED FOR EVALUATION BY OUR QUALITY ENGINEER TEAM. THE RETAINED NEEDLE SAMPLES WERE ASSEMBLED WITH A BD SYRINGE BY FOLLOWING REGULAR PRACTICES AND POSITIONING THE HUB ONTO THE SYRINGE TIP WITH A SLIGHTLY ROTATIONAL MOVEMENT. THE RETAINED SAMPLES DID NOT PRESENT THE REPORTED DEFECT AND NO SIGNS OF DEFECTIVE HUB CONNECTION WERE OBSERVED. BASED ON THE INVESTIGATION RESULTS, AN EXACT CAUSE RELATED TO THE MANUFACTURING PROCESS COULD NOT BE DETERMINED FOR THIS INCIDENT. PER THE PROVIDED FEEDBACK, WE UNDERSTAND A DEFECTIVE CONNECTION TOOK PLACE. BASED ON OUR EXPERIENCE, THIS ISSUE COULD RESULT FROM DEFECTIVE LUER DIMENSIONS, DAMAGE TO THE SYRINGE TIP, OR AN INEFFECTIVE ADJUSTMENT BETWEEN THE DEVICES BY THE END USER. WITH THE PREVENTIVE MEASURES IN PLACE, WE BELIEVE THIS WAS AN ISOLATED INCIDENT WITH AN UNLIKELY CHANCE OF RECURRENCE. AT THIS TIME, FURTHER ACTION HAS NOT BEEN DETERMINED NECESSARY. OUR QUALITY TEAM WILL CONTINUE TO CLOSELY MONITOR THE MANUFACTURING PROCESS FOR SIGNS OF THIS POTENTIAL DEFECT AND ANY EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD CONVENTIONAL NEEDLES; NEEDLE COMES OFF SYRINGE THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM DUTCH TO ENGLISH: I WAS PREPARING MEDICATION, DON'T REMEMBER IF IT WAS IV OR INHALED MEDICATION. I TAPPED, NO DIFFERENTLY THAN USUAL, THE AIR BUBBLES IN THE SYRINGE AND TAPPED THE NEEDLE OFF THE SYRINGE. I THOUGHT THIS WAS A COINCIDENCE AND CLUMSINESS, SO I GRABBED A NEW NEEDLE AND PUT IT ON THE SYRINGE. WHEN I TAPPED UP THE BUBBLES AGAIN, THE NEEDLE CAME OFF THE SYRINGE AGAIN, WHICH CAME INTO MY FACE. I DIDN'T HURT MYSELF, BUT I WONDER IF THIS WAS REALLY CLUMSINESS OR A MISTAKE IN THE BATCH. I NOTICED THAT THE NEEDLE DIDN'T GET ON THE SYRINGE VERY WELL.

    Description of Event or Problem · 0

    ANSWER RECEIVED ON 21.10.20241. CAN YOU CONFIRM THE DEFECT WAS IDENTIFIED BEFORE USE OR DURING USE? I IDENTIFIED THE DEFECT WHILE USING THEM. IT HAPPENED TWO TIMES IN A ROW.2. WHAT WAS THE MEDICATION USED? I USED NACL 0,9%, NO MEDICATION.3. WHAT THERE ANY LEAKAGE OF MEDICATION DUE TO EVENT? THERE WAS NO LEAKAGE DURING USE.ANSWER RECEIVED 28.10.20241. COULD YOU PLEASE CONFIRM IF TWO EVENTS HAPPENED OF SAME DAY? IF THE 2 EVENTS HAPPENED ON DIFFERENT DAY, PLEASE PROVIDE THE DATE.BOTH INCIDENTS HAPPENED IN THE SAME 5 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    33428 BD CONVENTIONAL NEEDLES PERIPHERAL IV CATHETERS FMI BECTON DICKINSON, S.A. 240504 00382903031290

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown